Jersey City, N.J. — Organon (NYSE: OGN), a global healthcare company specializing in women’s health, announced it will discontinue development of its investigational endometriosis treatment OG-6219 following disappointing results from the Phase 2 ELENA proof-of-concept study.
The study evaluated OG-6219, an oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor acquired through Organon’s 2021 acquisition of Forendo Pharma, in pre-menopausal women experiencing moderate-to-severe endometriosis-related pelvic pain. The randomized, double-blind, placebo-controlled global trial did not meet its primary efficacy endpoint. Patients receiving OG-6219 showed no significant improvement in overall pelvic pain compared to those receiving placebo.
“While these study results are disappointing, Organon remains committed to our long-term vision to create a better and healthier every day for all women, including those living with endometriosis,” said Dr. Juan Camilo Arjona Ferreira, Head of Research & Development and Chief Medical Officer at Organon. “We are grateful to all the patients, caregivers, and investigators for their participation and support of this study.”
The Phase 2a/b ELENA study (NCT05560646) included pre-menopausal women aged 18 to 49 who had been surgically diagnosed with endometriosis. Participants were randomized to receive one of three doses of OG-6219 or placebo, taken orally twice daily for three months. The study’s primary goal was to assess changes in mean pelvic pain scores from baseline to the final treatment cycle, measured using an 11-point numerical rating scale.
Organon’s decision to discontinue the OG-6219 program reflects the challenges of developing new therapeutics for endometriosis, a condition affecting millions of women worldwide. Despite the setback, the company affirmed its continued focus on addressing unmet needs in women’s health.
